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GVAX® Vaccine for Prostate Cancer vs Docetaxel & Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00089856
Recruitment Status : Terminated (Based on futility analysis showing <30% chance of meeting primary endpoint.)
First Posted : August 18, 2004
Last Update Posted : November 5, 2008
Information provided by:
Cell Genesys

Brief Summary:
The purpose of this study is to compare the duration of survival between GVAX® immunotherapy for prostate cancer and chemotherapy treatment in patients with prostate cancer who no longer respond to hormone therapy, who have documented metastases, and who have not been treated with chemotherapy in the past.

Condition or disease Intervention/treatment Phase
Prostate Cancer Biological: Immunotherapy with allogeneic prostate vaccine Drug: Chemotherapy (Taxotere and prednisone) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 626 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Randomized, Open-Label Study of CG1940 and CG8711 Versus Docetaxel and Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer Who Are Chemotherapy-Naïve
Study Start Date : July 2004
Primary Completion Date : October 2008
Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Standard of care - chemotherapy
Drug: Chemotherapy (Taxotere and prednisone)
Chemotherapy (Taxotere and prednisone)
Experimental: 1
Biological: Immunotherapy with allogeneic prostate vaccine
Immunotherapy with allogeneic prostate vaccine

Primary Outcome Measures :
  1. Survival [ Time Frame: 0 ]

Secondary Outcome Measures :
  1. Bone pain and bone related events [ Time Frame: 0 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Confirmed diagnosis of or clinical history consistent with adenocarcinoma of the prostate
  • Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy
  • Detectable metastases
  • Any Gleason score
  • ECOG performance status 0-2

Exclusion Criteria:

  • Prior treatment with chemotherapy
  • Prior Immunotherapy
  • Prior treatment with gene therapy
  • Significant cancer related pain

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00089856

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Sponsors and Collaborators
Cell Genesys

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cell Genesys, Inc, Cell Genesys, Inc.
ClinicalTrials.gov Identifier: NCT00089856     History of Changes
Other Study ID Numbers: G-0029
First Posted: August 18, 2004    Key Record Dates
Last Update Posted: November 5, 2008
Last Verified: November 2008

Keywords provided by Cell Genesys:
Allogeneic cells
Advanced Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal